Applies to the safety of medical electrical systems, as defined as follows:combination of items of equipment, at least one of which must be medical electrical equipment and inter-connected by functional connection or use of a multiple portable socket-outlet.Describes the safety requirements necessary to provide protection for the patient, the operator and surroundings.Cancels and replaces the first edition published in 1992 and its amendment 1 (1995) and constitutes a technical revision.
This standard is the first of a new series of collateral standards that specify general requirements for safety applicable to a group of electromedical equipment not fully addressed in the General Standard. This publication deals with safety requirements for medical electrical systems.
It includes primarily a revision of the requirements of the separation devices regarding creepage distances and air clearances. Requirements for muliple portable socket-outlets when used in systems are included.
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